Poly-hapten with topical hormone alopecia hair regrowth system

ABSTRACT

A hair regrowth system consisting of sensitization, growth, and maintenance kits for alopecia areata and related alopecia balding conditions. Graduated doses of specific engineered and or extracted haptens are included in a sensitization kit for initiating immune system response in hairless areas. A growth kit containing topical hormones to increase papilla size and vigor and a maintenance kit to sustain immune system response and papilla size and vigor for the long term are included in some embodiments.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional application of U.S. patent applicationSer. No. 13/305,280 which was filed with the United States Patent andTrademark Office on Nov. 28, 2011, the entire contents of which isherein incorporated by reference.

FIELD OF THE INVENTION

The present invention relates generally to means and method of reversingalopecia areata, or treating other hair loss conditions, at leasttemporarily and, specifically to a kit and substance employed to triggeran immune response through contact dermatitis using Urushiol.

BACKGROUND

Alopecia areata is an autoimmune disease associated with hair folliclesthat can result in hair loss. Hair loss resulting from alopecia areatacan occur anywhere on the body and can be patchy hair loss or total hairloss. Other similar conditions that can result in hair loss include, forexample, pattern baldness, hypotrichosis, and other types of alopeciaincluding, for example, alopecia androgenetica, alopecia areata diffusa,alopecia areata ophiasis, alopecia barbae, alopecia cicatricial,alopecia marginalis, alopecia mucinosa, alopecia partialis, alopeciatotalis, alopecia universalis, congenial alopecia, reticular alopeciaareata, sisaipho alopecia areata, syphilitic alopecia, and tractionalopecia.

Dermatologists typically treat alopecia and related balding conditionswith chemical agents such as cortical steroids and squaric acid dibutylester (SADBE). SADBE causes an immune system response known as contactdermatitis, which sensitizes the immune system, thereby assisting theimmune system in decreasing underlying inflammation responsible for thehair loss. Cortical steroids suppress all immune system response.However, this type of treatment is only successful for a percentage ofthe population because different people have different sensitivitythresholds and, in fact, many people have no reaction to the SADBEagents at all rendering it completely ineffective in those cases.Cortical steroids likewise only work in a percentage of the population.Exactly how this or other contact sensitizers work is not really known.It is thought that it could be antigen competition, that they divert theattention of the inflammatory cells to them, thus moving them away fromthe hair follicles and allowing the affected area to re-grow.

Other means of treating hair loss have been disclosed. Some of these aredisclosed in United States patents or applications. For example, U.S.patent application Ser. No. 11/471,827 discloses a composition thatincludes dihydrotestosterone blocker and a thyroid source.Alternatively, the composition may include an estrogen source and athyroid sourcerelates to uses of T3 (triiodothyronine) but does notdisclose an immune sensitizer or any contact dermatitis agent. U.S.patent application Ser. No. 10/077,289 describes compositions whichallegedly stimulate stem cells and/or bulge cells to create new hairfollicular cells, to enhance blood flow to hair follicles resulting inthe activation and transition of stem cells to active cells yieldingterminal hair growth. The active molecule reported in this invention arenaturally occurring phytosterol, particularly, 13-sitosterol. Ingeneral, for topical administration, formulated in combination with oneor more excipients. U.S. patent application Ser. No. 10/584,766 relatesto the use of IL-15 polynucleotides, polypeptides or compounds whichbind to an antibody which specifically recognizes the IL-15 polypeptideor which specifically bind to an IL-15 receptor alpha chain for thepreparation of a composition described as stimulating hair growth or fortreating, preventing and/or ameliorating hair loss. U.S. patentapplication Ser. No. 11/089,146 purports to provides methods andcompositions for treating hair loss, including arresting and/orreversing hair loss and/or promoting hair growth, in mammals, such ashumans, companion animals and livestock, using certain thyromimeticcompounds. U.S. patent application Ser. No. 12/996,899 discloses acomposition comprising cardiac glycoside which may be the only activeingredient present in the composition. The cardiac glycoside may beadjunctively administered with at least one active ingredient, i.e. thecomposition may further comprise adjuvant compounds which exhibitefficacy in treating hair loss disorders and may comprise at least onecomponent selected from the group consisting of a steroid, anindole-based compound, an anti-fungal agent, an anti-inflammatory agentand a cooling or antipruritic agent.

SUMMARY

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used, in isolation, as an aid in determining the scope of the claimedsubject matter. At a high level, embodiments of the invention relate toa hair re-growth method dependent upon self-inflicted contact dermatitisand followed by follicle hormone stimulation to induce hair regrowth anda kit or method that includes Urushiol.

Various embodiments of the hair re-growth method can be used fortreating and/or preventing, hair loss. “Hair loss,” as the term is usedherein refers to a loss of hair that can result from any number ofconditions, diseases, or the like, including, for example, alopecia andhypotrichosis.

Urushiol is present in the oil produced by the poison ivy plant andseveral other plants. It may also be engineered. Many people have a highsensitivity to Urushiol, estimates are that 85% of the population willshow allergic reaction to it. By utilizing embodiments of the invention,a larger percentage of the population in need of treatment for hair losscan be successfully treated by using Urushiol to enhance an immunesystem response in those for whom SADBE alone is ineffective. In someembodiments, for example, the treatment success can be expanded toapproximately 95% of the population in need of treatment.

A Hapten is a type of antigen that elicits production of antibodies onlywhen combined with another antigenic molecule, such as immunogen. It canalso react with previously existing antibodies. An example of a haptenis Urushiol but there are many. The method of the present invention alsocontemplates using mixtures of haptens where the mixture includesUrushiol.

A first illustrative embodiment of the present invention relates tosimply applying a Urushiol mixture to the affected area i.e. the areawhere hair loss is evident until the area becomes sensitized (a reactioncan be detected). On occasion this simple stimulation of the immunesystem may induce hair regrowth.

A second illustrative embodiment of the present invention relates to amethod of reversing hair loss that includes application of specific andmultiple doses at a level determined to be at or near the sensitizationthreshold of the user over a specific time period of a preparation thatincludes Urushiol.

A third illustrative embodiment of the present invention relates to amethod of reversing hair loss that starts with a first phase. Apreparation made with at least Urushiol is applied to the area wherehair loss has occurred over a given time period to determine anappropriate level that causes adequate sensitization of the affectedarea. The method may include recommendations for how much, how often andhow many times the preparation should be used to determine sensitizationlevel. The sensitization dosage of Urushiol in the preparation may bethe same and used a plurality of time throughout the time period of asecond phase or may be of graduated dosage of one or more ingredients,including Urushiol, or may vary in accordance with the method. A thirdphase may then be employed where level of the preparation containingUrushiol is applied less often with the objective of maintaining hairregrowth. If hair regrowth ceases or slows, the user may begin the firstphase again and proceed until results are achiever.

Another embodiment may employ the same approach as the third embodimentjust described and further includes application to the area of hair lossof a preparation made with at least one, and perhaps a combination ofseveral, thyroid and other hormone(s) including prostaglandins andprostaglandin analogs to stimulate the follicles to a state where hairregrowth occurs. This preparation may also be used to first determine asensitization dose, then applied in a routine purposed to start regrowthand, thereafter, with less frequent applications for maintenance. Themethod may include recommendations for how much, how often and how manytimes the hormone preparation should be used. Further, the dosage andrelative levels of hormone(s) may be of uniform dosage or may includegraduated dosages of some or all of the hormone(s) in the preparationfor use in determining sensitization dosage to use during the secondphase, regrowth. Finally, the embodiment may include a thirdpreparation. This one is intended to maintain the hair follicles in astate stimulated to continue normal hair growth. While this routine maybe all that is necessary for a given patch of baldness, it may berepeated as needed. Further, the method may include more or lessapplications of the Urushiol preparation as compared to the preparationincluding hormones. Finally, the method may include an alternation ofthe Urushiol preparation and the hormone preparation, or may recommendan alternating pattern of application of these two preparations orrecommend some other pattern prior to recommending application of themaintenance preparation. It is intended there will be kits with andwithout hormones as needed to treat the affected population.

These and other aspects of the invention will become apparent to one ofordinary skill in the art upon a reading of the following description,drawings, and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is described in detail below with reference to theattached drawing figures, wherein:

FIG. 1 is a flow chart depicting an illustrative method of treating hairloss in accordance with embodiments of the invention; and

FIG. 2 is another flow chart depicting an illustrative method oftreating hair loss in accordance with embodiments of the invention.

DETAILED DESCRIPTION

The subject matter of embodiments of the invention disclosed herein isdescribed with specificity to meet statutory requirements. However, thedescription itself is not intended to limit the scope of this patent.Rather, the inventors have contemplated that the claimed subject mattermight also be embodied in other ways, to include different steps orcombinations of steps similar to the ones described in this document, inconjunction with other technologies. Moreover, although the term “step”is used herein to connote different elements of methods employed, theterm should not be interpreted as implying any particular order among orbetween various steps herein disclosed unless and except when the orderof individual steps is explicitly described.

With reference to the Drawings, and, in particular, to FIG. 1, a flowchart is presented that depicts an illustrative method of treating hairloss. As the term is used herein, “treating” can include any level oftreating (e.g., partially treating, completely treating, maintaining astatus quo associated with a condition, etc.), any level of preventing(e.g., partially preventing, completely preventing, preventing a changein a status quo associated with a condition, etc.), or any combinationthereof. Additionally, it should be understood that any number ofadditional steps and any number of variations on the steps describedherein can be utilized in various embodiments of the invention.

At a first illustrative step, step 102, a hair-loss patient uses asensitization kit. The sensitization kit facilitates sensitization ofthe immune system response, thereby increasing effectiveness of theoverall hair loss treatment method. According to various embodiments ofthe invention, the sensitization kit includes one or more doses atdifferent and graduated concentration levels of a sensitization mixture.The sensitization mixture includes Urushiol. In some embodiments, thesensitization kit includes one dose of the sensitization mixture, while,in other embodiments, the sensitization kit includes a number of dosesof the sensitization mixture. In some kits each dose of thesensitization mixture may vary from one or more of the others in thelevel (increase or decrease) of Urushiol it contains; in others thedoses are all uniform but may be applied in combination to determine theappropriate dosage to obtain sensitization.

According to various embodiments of the invention, an illustrativesensitization kit can include a number of graduated doses of thesensitization mixture. As the term is used herein, “graduated doses”refers to doses that increase in size (e.g., volume of the sensitizationmixture associated with the dose), strength (e.g., concentration ofUrushiol contained within the dose), or a combination of size andstrength. In embodiments, for example, each graduated dose of thesensitization mixture can include a different (e.g., increasing) amountof the sensitization mixture. In other embodiments, each dose of thesensitization mixture can include a different (e.g., increasing) amountof Urushiol (in which case, each dose can, but does not necessarily,include the same volume of sensitization mixture, but with differentconcentrations of Urushiol). In further embodiments, multiple doses in asensitization kit can include the same amount of sensitization mixtureand/or Urushiol. Any number of combinations or variations of the abovealso are contemplated as being within the ambit of the presentinvention. The dosages are typically applied in ascending order todetermine the sensitization level of the individual. The epidermis maybe scored before application if desired.

Embodiments of the sensitization mixture can include extracted Urushiol,engineered Urushiol, or a combination of extracted Urushiol andengineered Urushiol. Extracted Urushiol is Urushiol that is extractedfrom a natural source. Extracted Urushiol can include Urushiol extractedfrom any natural source or combination of natural sources. Naturalsources of Urushiol include, but are not limited to, plants of theToxicodendron genus (e.g., poison ivy, poison oak, poison Sumac, etc.),plants in the Anacardiaceae family (e.g., mango, Rengas tree, Burmeselacquer tree, India marking nut tree, cashew nut tree, etc.), and otherplants such as, for example, Ginkgo biloba.

Engineered Urushiol is Urushiol that is engineered, rather thanextracted from a natural source. In various embodiments, engineeredUrushiol can be optimized (i.e., the effectiveness of the engineeredUrushiol can be enhanced or selected to lengthen or shorten the theperiod when the skin is in a sensitized state) by the pattern of dosagesemployed, and the carrier with which the Urushiol is mixed. EngineeredUrushiols may be included in the sensitization mixtures

According to embodiments of the invention, the sensitization mixturescan include one or more other chemical agents in addition to Urushiol(natural or engineered) such as, for example, dinitrochlorobenzene(DNCB), diphenylcyclopropenone (DPCP), or SADBE. Additionally, inembodiments, the sensitization kit can include other chemical agents tobe applied by the hair loss patient such as, for example,corticosteroids, androgenic receptor antagonist agents, caffeine,Ketoconazole, Dihydrotestosterone inhibiting agents, thyroid hormones,prostaglandins or the like. In some embodiments, the sensitizationmixture can include any one or more of these additional chemical agents,while, in other embodiments, any one or more of these chemical agentscan be applied independently of the sensitization mixture, as part ofthe sensitization kit.

In various embodiments, the sensitization mixture and/or other chemicalagents can be integrated with any number of various applicationmechanisms such as, for example, alcohol, acetone, aqueous or othersolvent delivery systems, wipes (e.g., pre-moistened wipes), cream,lotion, powder, gel, or the like. In an embodiment, for example, thesensitization mixture is applied using a roll-on applicator. In anotherembodiment, for example, the sensitization mixture is applied using aspill-proof blotter applicator. In embodiments, the applicators andother containers described herein can be equipped with child-resistantlids or other safety devices. Similarly, the chemical agents employed inthe various mixtures described herein can include taste bitterants,fragrances, and the like. It should be understood that the sensitizationkit and mixture, as well as the re-growth 104 and maintenance kits 106,can include any or all of these additional items and features tofacilitate effectiveness, safety, and the like. For example, in someembodiments, the sensitization kit includes sterile sandpaper packets orsticks for scoring the epidermis prior to application of chemicalagents. These may continue to be used during growth and maintenancephases.

This engineered Urushiol and SADBE, and or other commonly used contactdermatitis agents mixture, is hereby introduced as a poly-haptenolmixture employed in the sensitization kit. After sensitization occurs,and the sensitization dosage level is determined, a subsequent treatmentreferred to at FIG. 1 as use of the Growth kit (104) comprisingapplication of a growth-enhancing mixture is employed. Preferably, thegrowth kit includes a growth mixture comprising at least one andpreferably a mixture of thyroid hormones T3, T4, T1a and T0a and otherhormones such as prostaglandins and prostaglandin analogs in addition tourushiol at or near the sensitization level determined previously. Thegrowth mixture is applied topically directly to the papilla and follicleincreasing papilla vigor and size. This is the growth kit 104. It isdesigned to rapidly initiate growth after the sensitization phase hasrendered the immune system attack on the hair follicles ineffective. Thegrowth-enhancing mixture may include multiple doses to be applied atscheduled intervals. The doses may be the same, graduated, or may bevaried, all as related to the level of thyroid hormone or hormones. Thedoses or some of the doses may include Urushiol and the same or variedlevels or at or near the sensitization leve determined previously. Thegrowth kit may direct the user to apply the doses in predetermined orderor to change from one dose to another based on one or more physicalresults. Lastly, a maintenance kit 106 for longer term use to maintainthe results produced from the initial treatment is used. FIG. 1 (106).The maintenance kit may contain multiple doses of a maintenance mixture.The maintenance mixture may comprise one or more thyroid hormones,prostaglandins or Urushiol, or two or more hormones. The relative levelsof hormones or Urushiol or both may differ from dose to dose or beuniform, and the kit may include a recommended order of doses toaccomplish a pattern intended to maintain the hair growth.Alternatively, the kit may include description(s) of one or morephysical results.

If the maintenance kit seems to lose its effect for inducing hairregrowth, the method may be re-applied in its entirety, or partially.The growth kit may be employed; or the sensitization kit may be usedagain, partially or entirely, depending on its effects, to re-determinea sensitization level.

The topical doses of Thyroid and other hormones employed by the kits andthe method as a whole are considered non-therapeutic surface dosesbecause they are only delivering a non-therapeutic amount of thyroidhormone systemically to the blood and a therapeutic dose directly to thepapilla. Papilla and Follicular response to Thyroid hormone treatmentincreases the size and vigor of the papilla and follicle in rats andmice.

In order to dramatically increase alopecia treatment success, the firstphase of treatment, referred to as sensitization, must be optimized.Although it is possible to simply start with a growth kit that includesa dose that causes sensitivity in many people and this inventionincludes such an embodiment, the proposed optimization includesproviding a graduated dosage sensitization kit including multiplechemicals, some of which may be engineered, to facilitate thesensitization reaction necessary for hair regrowth to start. It isbelieved that determining the sensitization level for the user mayprovide a better likelihood of getting results from the least possibleexposure. Once regrowth starts, the optional second phase (growth) oftreatment can begin. This phase includes continued polyhaptenolsensitization and papilla/follicular growth stimulation by a hormone ora mixture of Triiodothyronine T3, thyroxine T4, iodothyronamine (T1a)and thyronamine (T0a) prostaglandins and prostaglandin analogs. Oncehair regrowth starts and papilla size and vigor are increased tosufficient levels, a maintenance kit can be used which contains the sameitems found in the sensitization and growth kits but provides a scheduleand dosages consistent with maintaining hair growth.

The present invention has been described in relation to particularembodiments, which are intended in all respects to be illustrativerather than restrictive. Alternative embodiments will become apparent tothose of ordinary skill in the art to which the present inventionpertains without departing from its scope.

From the foregoing, it will be seen that this invention is one welladapted to attain all the ends and objects set forth above, togetherwith other advantages which are obvious and inherent to the system andmethod. It will be understood that certain features and subcombinationsare of utility and may be employed without reference to other featuresand subcombinations. This is contemplated by and is within the scope ofthe claims.

The invention claimed is:
 1. A skin sensitization kit for inducing an immune system response in a generally hairless region of skin, comprising: a plurality of doses of a sensitization mixture, the mixture including Urushiol.
 2. The skin sensitization kit of claim 1, wherein the immune system response includes Urushiol-induced contact dermatitis.
 3. The skin sensitization kit of claim 1, wherein the sensitization mixture further includes at least one chemical selected from the group of dinitrochlorobenzene (DNCB), diphenylcyclopropenone (DPCP), and squaric acid dibutyl ester (SADBE).
 4. The skin sensitization kit of claim 1, wherein the Urushiol includes extracted Urushiol.
 5. The skin sensitization kit of claim 1, wherein the Urushiol includes engineered Urushiol.
 6. The skin sensitization kit of claim 5, wherein the Urushiol includes a combination of extracted and engineered Urushiol.
 7. The skin sensitization kit of claim 1, wherein the plurality of doses are graduated.
 8. The skin sensitization kit of claim 7, wherein a first one of the plurality of doses includes a first amount of Urushiol and a second one of the plurality of doses includes a second amount of Urushiol.
 9. The skin sensitization kit of claim 1 comprising at least two doses.
 10. The skin sensitization kit of claim 1, wherein at least one of said doses contains a different level of Urushiol than another of said at least two doses.
 11. The skin sensitization kit of claim 10 further comprising at least one applicator for said at least two doses.
 12. The skin sensitization kit of claim 11 wherein the at least one applicator are usable for applying the at least two doses in an order.
 13. The skin sensitization kit of claim 1, further comprising: a safety taste bitterent.
 14. The skin sensitization kit of claim 1, further comprising: at least one of sterile sandpaper packets and sticks for scoring the epidermis.
 15. The skin sensitization kit of claim 1, further comprising: a spill proof blotter applicator with child resistant lid configured to deliver the sensitization mixture.
 16. The skin sensitization kit of claim 1, wherein said sensitization mixture further comprises at least one from the group consisting of: corticosteroid, Thyroid Hormones, or prostaglandins.
 17. The skin sensitization kit of claim 1, wherein the sensitization mixture contains an alcohol, a gel, or a roll-on gel delivery system.
 18. A growth kit comprising a growth mixture having a pre-determined sensitization dosage of Urushiol.
 19. The skin sensitization kit of claim 1, A growth kit comprised of predetermined doses of Urushiol and SADBE made into sealed wipes kit with different colors for the different doses.
 20. A skin sensitization kit for inducing an immune system response in a generally hairless region of skin, comprising: a plurality of doses of a sensitization mixture, the mixture including SABDE. 